Obstructive Sleep ApneaEarly Phase 1NCT04230681
Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery
A Early Phase 1 study testing Hydromorphone and Fentanyl in people with Obstructive Sleep Apnea and Tonsillitis, run by Washington University School of Medicine at 1 site in United States.
Trial summary
A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery. Read more about this study
- Who is it for?
- Ages 2 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Tonsillitis
- What is being tested?
- Hydromorphone and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2020to 1 Apr 2022
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children ages 2 to 15 years old
- Presenting for tonsillectomy or adenotonsillectomy surgery
- American Society of Anesthesiologists Physical Status (ASAPS) Classification 1, 2 or 3
- Provide Informed Consent / Assent (as appropriate)
Who cannot join
- Additional Concurrent surgeries, exclusive of myringotomy tubes, minor oral/nasal procedures (e.g. frenulectomy), and endoscopic procedures
- Revision tonsillectomy or revision adenotonsillectomy surgery
- Known pregnancy
- Any condition which would make the participant, in the opinion of the investigator or the attending anesthesiologist caring for the patient, unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine/Barnes-Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: A Randomized Controlled Trial to Compare Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery
A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.
Read the detailed description
This is a randomized clinical trial with masked assessment, comparing recovery indices for patients receiving intermediate acting versus short acting opioid analgesia using hydromorphone or fentanyl as intraoperative analgesics. An otherwise standardized anesthetic and analgesic regimen will be utilized, consistent with routine care at SLCH. Patients will be randomized 1:1 in block sizes of 5 per group. Patients will be randomized to receive either hydromorphone or fentanyl throughout the perioperative period by opening a sealed protocol envelope.
- Conditions
- Obstructive Sleep Apnea, Tonsillitis
- Being tested
- Hydromorphone, Fentanyl
- Medical subject headings
- Sleep Apnea, Obstructive, Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
Patients will be randomized to one of two opioids for the treatment of post-operative pain.
FentanylDrug
Fentanyl
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Active comparator | Not described Receives: Drug: Fentanyl |
| Hydromorphone | Active comparator | Not described Receives: Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Requiring Rescue Intravenous Opioid
Number
Measured: up to 6 hours post surgery
Secondary outcomes (4)
Evaluation of Participant's Pain
Revised Face, Legs, Activity, Cry, Consolability (rFLACC) Scale Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0=no pain/relaxed, 10=distressed/in pain
Measured: Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.
Evaluation of Participant's SpO2 Saturation
SpO2 %
Measured: Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.
Respiratory and PONV Events in PACU
Measured: up to 6 hours following surgery
Respiratory and PONV Events at Home
Survey sent to parent by email postoperatively
Measured: up to 7 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start26 Feb 2020
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Michael Montana, MD PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230681
- Sponsor's protocol ID
- 201912042
- Other IDs
- UL1TR002345
- Status last verified
- Nov 2024
- First submitted
- 27 Dec 2019
- Last updated
- 18 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Friedman NR, Perkins JN, McNair B, Mitchell RB. Current practice patterns for sleep-disordered breathing in children. Laryngoscope. 2013 Apr;123(4):1055-8. doi: 10.1002/lary.23709. Epub 2013 Feb 4.
PubMed 23382017Brown KA. Outcome, risk, and error and the child with obstructive sleep apnea. Paediatr Anaesth. 2011 Jul;21(7):771-80. doi: 10.1111/j.1460-9592.2011.03597.x. Epub 2011 May 3.
PubMed 21539679Bhattacharyya N, Lin HW. Changes and consistencies in the epidemiology of pediatric adenotonsillar surgery, 1996-2006. Otolaryngol Head Neck Surg. 2010 Nov;143(5):680-4. doi: 10.1016/j.otohns.2010.06.918.
PubMed 20974339Miller GC, Hifko AJ, Lieu JK, Nguyen JT, Lieu JEC, Montana MC. A Triple-Blinded, Randomized, Controlled Trial Comparing Hydromorphone vs. Fentanyl for Children Undergoing Tonsillectomy. Paediatr Anaesth. 2026 Jun 18. doi: 10.1002/pan.70240. Online ahead of print.
PubMed 42312422
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Compare Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery
- ClinicalTrials.gov ID
- NCT04230681
- Acronym / sponsor ID
- 201912042
- Conditions
- Obstructive Sleep Apnea, Tonsillitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Posted 18 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.
Detailed description
This is a randomized clinical trial with masked assessment, comparing recovery indices for patients receiving intermediate acting versus short acting opioid analgesia using hydromorphone or fentanyl as intraoperative analgesics. An otherwise standardized anesthetic and analgesic regimen will be utilized, consistent with routine care at SLCH. Patients will be randomized 1:1 in block sizes of 5 per group. Patients will be randomized to receive either hydromorphone or fentanyl throughout the perioperative period by opening a sealed protocol envelope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Active comparator | Drug: Fentanyl |
| Hydromorphone | Active comparator | Drug: Hydromorphone |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children ages 2 to 15 years old
- Presenting for tonsillectomy or adenotonsillectomy surgery
- American Society of Anesthesiologists Physical Status (ASAPS) Classification 1, 2 or 3
- Provide Informed Consent / Assent (as appropriate)
Key exclusion criteria (4 listed)
- Additional Concurrent surgeries, exclusive of myringotomy tubes, minor oral/nasal procedures (e.g. frenulectomy), and endoscopic procedures
- Revision tonsillectomy or revision adenotonsillectomy surgery
- Known pregnancy
- Any condition which would make the participant, in the opinion of the investigator or the attending anesthesiologist caring for the patient, unsuitable for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydromorphonePatients will be randomized to one of two opioids for the treatment of post-operative pain. | Drug | Hydromorphone |
| FentanylFentanyl | Drug | Fentanyl |
Primary outcome
Number of Patients Requiring Rescue Intravenous Opioid
Time frame: up to 6 hours post surgery
Number
4 secondary outcomes
Evaluation of Participant's Pain
Time frame: Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.
Evaluation of Participant's SpO2 Saturation
Time frame: Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.
Respiratory and PONV Events in PACU
Time frame: up to 6 hours following surgery
Respiratory and PONV Events at Home
Time frame: up to 7 days following surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23382017Friedman NR, Perkins JN, McNair B, Mitchell RB. Current practice patterns for sleep-disordered breathing in children. Laryngoscope. 2013 Apr;123(4):1055-8. doi: 10.1002/lary.23709. Epub 2013 Feb 4.
- Background: PubMed 21539679Brown KA. Outcome, risk, and error and the child with obstructive sleep apnea. Paediatr Anaesth. 2011 Jul;21(7):771-80. doi: 10.1111/j.1460-9592.2011.03597.x. Epub 2011 May 3.
- Background: PubMed 20974339Bhattacharyya N, Lin HW. Changes and consistencies in the epidemiology of pediatric adenotonsillar surgery, 1996-2006. Otolaryngol Head Neck Surg. 2010 Nov;143(5):680-4. doi: 10.1016/j.otohns.2010.06.918.
- Derived from this study: PubMed 42312422Miller GC, Hifko AJ, Lieu JK, Nguyen JT, Lieu JEC, Montana MC. A Triple-Blinded, Randomized, Controlled Trial Comparing Hydromorphone vs. Fentanyl for Children Undergoing Tonsillectomy. Paediatr Anaesth. 2026 Jun 18. doi: 10.1002/pan.70240. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Montana, MD PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hydromorphone and Fentanyl in people with Obstructive Sleep Apnea and Tonsillitis, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Requiring Rescue Intravenous Opioid (time frame: up to 6 hours post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04230681, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.